Various methods and machines have been used in the past to measure electrical characteristics of living tissue for purpose of locating an area of abnormal nervous system activity. However, whereas prior art methodologies merely allow for the detection of pain, the apparatus, system and method of the present invention allow for the objective assessment pain severity that finds utility not only the initial diagnosis but also the on-going treatment of any disease, disorder or injury associated therewith. To that end, the apparatus, system and method of the present invention allows medical practitioners to non-invasively and quantitatively distinguish organic pain from psychosomatic pain and legitimate pain patients from drug seekers and opiod addicts, as well as to directly and objectively compare the efficacy of different drug regimens and therapy protocols.
Legal claims defining the scope of protection, as filed with the USPTO.
1. A system for the objective measurement of the degree of sympathetic nerve dysfunction and thus the severity of an underlying injury, disease, or disorder present at one or more target sites in a subject, said system comprising: a. a sensor head that includes a concentric bipolar electrode assembly configured to contact the skin of a subject at one or more target sites, apply a low voltage electrical signal to said target site for a pre-determined period of time, and thereby measure an absolute selective tissue conductance (STC) value associated with each of said one or more target sites, b. a command module that contains the requisite power, circuitry, and communication components to enable the activation of said sensor head, application of said electrical signal, and recordation of said absolute STC value(s) measured thereby; and c. an algorithm maintained by said command module that converts the absolute STC value(s) measured by said sensor head at each of said target site(s) into a scaled output correlated to the degree of sympathetic nerve dysfunction, wherein said algorithm includes the steps of: (1) automatically comparing an absolute STC value obtained from a first target site to a reference STC value obtained from: i. one or more second target sites on said subject, wherein said one or more second target sites comprise mirrored and/or bilateral equivalent(s) of said first target site; ii. prior readings for said subject at said first target site; iii. a database of absolute and relative STC data obtained from pain and/or normal pain-free patients; or iv. a combination thereof (2) calculating a degree of difference between said absolute STC value and said reference STC value, and (3) converting the degree of difference calculated in step (2) to a scaled output that corresponds to severity of an underlying sympathetic nerve dysfunction.
2. The system of claim 1 , wherein said electrical signal is a high frequency AC signal in the range of 1 to 100 kHz.
3. The system of claim 1 , wherein said algorithm includes the step of comparing the absolute STC value measured at a first target site to an absolute STC value measured at a second target site that is the bilateral mirror of said first target site.
4. The system of claim 1 , wherein said sensor head is physically separated from said command module and said command module communication component(s) is/are configured to send and receive wireless signals to and from said sensor head, further wherein said sensor head includes its own power supply, means to record measurements, and means to transmit recorded measurements to said command module.
5. The system of claim 4 wherein said means to record measurements comprises an integral or on-board memory chip or memory card.
6. The system of claim 4 , wherein said command module comprises a smartphone, a tablet device or laptop, or a remote microprocessor.
7. The system of claim 1 , wherein said command module comprises a hand-held device housing and said sensor head is configured for ready attachment to and detachment from said hand-held housing.
8. The system of claim 7 , wherein the power components of said command module comprise one or more rechargeable batteries disposed within a compartment of said hand-held device housing.
9. The system of claim 7 , wherein said hand-held device housing further comprises a liquid crystal display, onboard microprocessor, and onboard data storage means to allow for collected data to be temporarily stored, recalled, analyzed and displayed until it can be downloaded or uploaded to a remote system.
10. The system of claim 7 , wherein said sensor head is configured for detachable mounting to said hand-held housing by means of a flexible coupling.
11. The system of claim 10 , wherein said flexible coupling comprises an articulated, pivoting base, further wherein said base includes a curved or ball type surface that is pivotably received in a mating socket on a distal neck portion of said device housing.
12. The system of claim 7 , wherein said sensor head is configured for detachable mounting to said hand-held housing by means of screw-in type mounting.
13. The system of claim 12 , wherein said screw-in type mounting is provided with spring loaded contact pins that complete a measurement circuit.
14. The system of claim 1 , wherein said sensor head further includes one or more additional biosensors for measuring one or more additional physiological parameters through contact with the skin at said one or more target site(s), further wherein said one or more additional biosensors are selected from the group consisting of: a. thermosensors and optical infrared scanners capable of assessing the heat and temperature of the subject's skin at said one or more target site(s); b. sweat-based glucose, lactate and theophylline biosensors that enable non-invasive transdermal scoring of analyte concentration in the muscle tissue proximate to said one or more target site(s); c. pulse-oximeters that allow for measurement of oxygen saturation levels and assess pre- and post-flow to one or more target site(s); and d. ultrasonic sensors and transducers that enable assessment of the viability and recovery of muscle tissue proximate to said one or more target site(s).
15. A kit for the objective measurement of the degree of sympathetic nerve dysfunction and thus the severity of any underlying injury, disease, or disorder present in a subject, said kit comprising: (a) the components of the system of claim 14 , including a plurality of said sensor heads, each in separate sterile wrappings and configured for disposable, single-use; (b) a series of pre-programmed montages that automate measurement of absolute STC values at a plurality of a neighboring target sites associated with a particular injury and comparison of said absolute STC values to a reference point to identify the presence of one or more asymmetries that correlate to the severity of nerve dysfunction; and (c) report-writing software.
16. A method for objectively measuring the degree of sympathetic nerve dysfunction and thus the severity of an underlying injury, disease, or disorder present at one or more target sites in a subject, wherein said method comprises the following steps: (a) identify a local area of tissue to be analyzed; (b) divide said tissue area into four quadrants; (c) using the system of claim 1 , apply a low voltage electrical signal via the entire active surface of the bipolar electrode assembly on said sensor head to a series of aligned target sites within a first quadrant for a pre-determined period of time and record absolute STC values for each target site; (d) repeat step (c) in the second, third, and fourth quadrant; (e) using the system algorithm, compare the absolute STC values for each target site and identify one or more sites of asymmetry; (f) using the system algorithm, further compare the absolute STC value obtained at said one or more sites of asymmetry to a reference STC value obtained from (a) a prior reading for said subject at said identical local area; (b) a database of STC data collected from pain and/or normal pain-free patients; or (c) a combination thereof; and (g) using said system algorithm, transduce the degree of difference between the absolute STC value at said one or more sites of asymmetry and the reference values in steps (e) and (f) to quantify the degree of sympathetic nerve dysfunction and thus the severity of an underlying nerve dysfunction located at said one or more sites of asymmetry within said local area of tissue.
17. The method of claim 16 , wherein said subject is a non-human animal.
18. The method of claim 16 , wherein said subject is a non-verbal human.
19. The method of claim 16 , further comprising the step of monitoring changes in absolute STC values at said one or more sites of asymmetry over time, before, during, and after the application of a first prescribed therapeutic regimen to determine the efficacy of said first therapeutic regimen in treating the underlying sympathetic nerve dysfunction associated therewith.
20. The method of claim 16 , further comprising the step of monitoring changes in absolute STC values at said one or more target sites of identified as exhibiting nerve dysfunction over time, before, during, and after the application of a second prescribed therapeutic regimen to determine the efficacy of said second therapeutic regimen relative to said first therapeutic regimen.
21. The method of claim 16 , further comprising the step of using said system algorithm to: (a) analyze differences in unilateral STC to discriminate among, diagnose and treat transient ischemic attacks (“TIA”), reversible ischemic neurological deficits, and completed unilateral hemispheric stroke, or (b) analyze STC regional differences to discriminate among, diagnose and treat various forms of migraine, cluster, tension, and other headache types.
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December 14, 2017
August 17, 2021
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